As Europeans await a decision by the European Union’s drug regulator on whether to approve
Covid-19 vaccine, German health authorities weighed in Thursday with a recommendation that the vaccine not be given to adults over aged 65.
The recommendation comes amid increasingly bitter squabbles between EU health authorities and AstraZeneca (ticker: (AZN)) over delivery timelines for its Covid-19 vaccine, and seems likely to complicate the vaccination effort. The European Medicines Agency, which regulates drugs for EU countries, is expected to announce its decision on whether to approve the vaccine on Friday.
AstraZeneca didn’t immediately respond to a request for comment on the German vaccine committee’s recommendation. AstraZeneca’s American depository receipts were up 0.2% in early trading on Thursday, after dropping 4.3% on Wednesday.
The new recommendation came from the Standing Vaccine Committee at the Robert Koch Institute, which sets vaccination schedules in Germany. It cited “insufficient data” on the vaccine’s effectiveness in people over 65 years old, according to Reuters.
An advisory against administering the vaccine to people over 65 would have an enormous impact on its usefulness, as Covid-19 presents the most serious risk in older age groups. According to the U.S. Centers for Disease Control and Prevention, adults aged 65 to 74 have a 90 times higher risk of death from Covid-19 than adults aged 18 to 29. The risk of death is 220 times higher for people aged 74 to 84.
The recommendation comes after days of pushback on reports by two top German newspapers earlier this week that the AstraZeneca vaccine had very low rates of efficacy in people over 65. The papers said at the time that government sources were worried the vaccine would not be approved for older adults.
AstraZeneca objected forcefully to those reports, calling them “completely incorrect,” according to Reuters. German health officials also criticized the newspaper reports, saying the papers misread trial data.
Yet the German committee’s decision seems to suggest that the newspapers were correct, at least, in highlighting the concerns of some German officials. Indeed, in its statement on Tuesday correcting the newspaper reports, the German government also criticized the small number of adults aged older than 65 who had been included in AstraZeneca’s trial.
The AstraZeneca vaccine is currently authorized for use in the UK., with no restrictions for people older than 65.
Even as German health officials raise their concerns, the feud between AstraZeneca and the European Union officials responsible for purchasing vaccine doses is worsening.
After the European commissioner for health and food safety slammed AstraZeneca in a Monday statement complaining that the company was delivering fewer doses in the short term than had been previously agreed, AstraZeneca’s CEO on Tuesday noted that his supply agreement with the EU was “not a contractual commitment” but a “best effort.”
On Wednesday, the EU dragged the UK. into the fight, saying that AstraZeneca should divert vaccines made in British factories to fill its commitments to the EU. The dispute continues Thursday, despite a meeting between the sides Wednesday night that the EU commissioner called “constructive.” Late Wednesday, the commissioner, Stella Kyriakides, tweeted: “Contractual obligations must be met, vaccines must be delivered to EU citizens.”
Meanwhile, data on a Phase 3 trial of the AstraZeneca vaccine run partially in the U.S. are expected in the coming weeks. The company made a presentation on Wednesday about the trial to the Centers for Disease Control and Prevention committee that makes vaccine- usage recommendations in the U.S. SVB Leerink analyst Geoffrey Porges said in a note Thursday that the presentation suggested that the company could be ready to present data on the trial in the next week or two.
“This means that by mid-February we will know if the two leading adenovirus vector COVID vaccines work, and if so, how well,” Porges said. “With JNJ’s phase 3 vaccine study reporting any day now, the next few weeks will provide a lot of data on the effectiveness of adenovirus-based immunization against COVID-19.”
Write to Josh Nathan-Kazis at email@example.com